Vasectomy devices and methods for their use

ABSTRACT

Conventional vasectomy techniques suffer from a number of disadvantages, including, for example, a substantial risk for the development of hematomas and swelling, a potential for spontaneous regeneration and undesired resumption of fertility, a need for a highly skilled surgical professional, as well as a long recovery period, accompanied by severe limitations on post-surgical activity. The present invention overcomes the disadvantages and deficiencies of the prior art by providing a rapid, reliable, less invasive male sterilization procedure as well as vasectomy instruments and kits for use therewith.

PRIORITY

This application claims the benefit of U.S. Provisional Application Ser.No. 62/917,325 filed Dec. 3, 2018, the contents of which are herebyincorporated by reference in their entirety.

TECHNICAL FIELD OF THE INVENTION

The present invention relates to surgical instruments, and moreparticularly to surgical instruments and kits for performing vasectomiesand methods for performing vasectomies using the instruments and kits.

BACKGROUND OF THE INVENTION

Vasectomy is surgical procedure that typically involves the removal of aportion of the ducts that carry sperm out of the testes (i.e., the vasdeferens), thereby stopping the flow of sperm from the testicle to theprostate gland; once the vas deferens is interrupted, the sperm cannotbe delivered and the man is rendered sterile. Currently used vasectomymethods, such as the No Scalpel Vasectomy (NSV), require that each vasdeferens be dissected from the scrotum to allow the clinician to occludeand divide the vas duct. Therein, the vas deferens is isolated,extracted, or otherwise delivered from the scrotum via one or twoopenings formed by puncturing the scrotum and then expanding theopening(s). The vas sheath is then retracted from a portion of the vasduct, which is then hemi-dissected and occluded, preferably by means ofmucosal cautery in which the distal end of the filament of a batterypowered cautery unit is inserted into each duct lumen and energized soas to create a luminal plug of scar tissue. Alternatively, vas occlusionmay involve ligation with a suture or surgical clip. In either case,after the vas is divided, a portion of the duct is optionally excisedand one end is isolated in the vas sheath to create a barrier toreconnection of the duct. For example, a layer of the vassal sheath maybe placed between the two severed ends of the vas in order to cover oneend but not the other in a technique referred to as “fascialinterpositioning”. Once both ends are sufficiently secured, the duct isthen returned to the scrotum, the incision is patched, and the procedureis deemed complete.

While the procedure appears simple, significant surgical skill isrequired, and complications may result. Most common of these is thearisal of hematomas caused by slow bleeders at the site of the ductocclusion and division. In non-elastic tissue, a small amount ofbleeding is quickly stopped by the tension that develops in the tissue.However, because the scrotum is essentially an elastic balloon-likevessel, the hydrostatic pressure necessary to stop bleeding is notpresent. Accordingly, even the slightest amount of persistent bleedingcan cause a tremendously large hematoma. In a similar manner, roughhandling of the tissue can lead to significant swelling. Even the mostexperienced vasectomy surgeon will occasionally encounter theseproblems.

Other disadvantages inherent in conventional surgical vasectomy, asexemplified by the NSV, include the prolonged surgical duration, whichis generally on the order of twenty minutes or more. In addition,conventional vasectomy procedures fail to adequately account for thenatural tendency of the cut ends of the vas deferens to grow backtogether, thereby allowing the flow of sperm to the prostate andresumption of fertility. Means for avoiding this failure have been thesubject of debate among those skilled in the art, the question beingwhether the vas deferens should be clipped, cut, cauterized, ligated, orall of the above. Finally, because sharp instruments are used,performing a vasectomy on HIV+ patients presents a risk to the surgeon.

U.S. Pat. Nos. 8,220,464 and 8,561,615, both to Pannell et al.represents an attempt to address the afore-noted drawbacks. Therein,Pannell et al. describe an instrument and method that overcomes some ofthese disadvantages of conventional vasectomy techniques, moreparticularly a bipolar coagulating device able to occlude a vas duct insitu, without dissecting the duct from the scrotum. In a preferredembodiment, the coagulating device includes an integral cutting elementable to excise a portion of scrotal tissue. In the context of thePannell method, a vas duct is located in a fold of scrotal skin andmaintained in that location by a clamp made of a dielectric material.The arcuate jaws of the bipolar coagulating device are positioned aroundthe clamp so as to compress a similarly arcuate region of tissue betweenthe jaws. The arcuate clamped region contains two portions of the vasduct trapped in the fold of scrotal tissue. After coagulating thearcuate clamped region, the clamp is removed so as to allow an integralcutting element pivotably mounted to the bipolar device to excise theuncoagulated tissue in the center of the arcuate region. Thus, theexcised tissue contains the uncoagulated portion of the vas duct betweenthe two coagulated regions sealed in the coagulated tissue fold.

The method described by Pannell et al. has significant advantages overother vasectomy methods. For example, because there is no dissection,there can be no bleeders and therefore no hematomas. Additionally, asthe procedure has fewer steps, it can be completed in much less time.Finally, extensive surgical skills are not required. However, due to theinclusion of an integral excision element, the Pannell device tends tobe complex, particularly if excision of the tissue is to be accomplishedelectrosurgically, as is the preferred embodiment. Also, when occludinga vas duct by the Pannell method, the clamp that maintains the positionof the duct in the fold and locates the fold in the jaws of thecoagulating device must be removed before excising the tissue portion.Removal of the clamp may allow the coagulated tissue to be displaced inthe jaws before or during excision of the tissue. Accordingly, it may benecessary for the clinician to exercise extreme care since displacementof the tissue may result in incomplete excision of the uncoagulatedcentral tissue portion. Given that tissue shrinks and forms a smoothlubricious surface when coagulated, such displacement may readily occur.

The present invention builds and improves upon the teachings of Pannellet al. described in U.S. Pat. Nos. 8,220,464 and 8,561,615, the contentsof which are incorporated by reference herein. In particular, thepresent invention is intended to simplify the vasectomy process so as toallow those less skilled to perform the procedure, as well as toovercome existing disadvantages and deficiencies in the prior artincluding, but not limited to, a substantial risk for the development ofhematomas and swelling, a potential, a need for a highly skilledsurgical professional, as well as a long recovery period, accompanied bysevere limitations on post-surgical activity.

Accordingly, the present invention addresses an ongoing need in the artfor vasectomy methods that utilize simplified instruments to occlude anddivide a vas duct simply and quickly and with fewer steps and fewerpost-surgical complications. To that end, the present invention furtheraddresses the need in the art for expeditious vasectomy methods thatprevent hematomas and swelling, that minimize the potential forspontaneous regeneration and undesired resumption of fertility, thatnegate the need for a highly skilled surgical professional, an extendedprocedure duration, and a prolonged recovery time. Finally, the presentinvention addresses the desire in the art for such new methods to avoidthe need for sharp instruments so that clinicians may limit theirexposure to a patient's body fluids and thus operate on patients withinfectious diseases such as HIV without risk of infection.

SUMMARY OF THE INVENTION

The present invention addresses the afore-noted needs in the art byproviding both novel vasectomy devices and instruments and novel methodsfor their use. For example, through the use of the excising instrumentsof the present invention, together with a bipolar coagulating device inmethods of the present invention, a vas duct may be quickly and simplyoccluded, divided, and separated by fascial interposition. For example,in a first embodiment, the present invention provides a novel vasectomymethod in which the requisite operations are accomplished in a singlestep, after the duct is dissected from the scrotum. In a second,alternative embodiment, the present invention allows for theseoperations to be accomplished in a single step without removing the ductfrom the scrotum. Further illustrative aspects and embodiments of thepresent invention in accordance with the foregoing objectives are asfollows:

It is an objective of the present invention to provide a surgical methodfor vasectomy in which the vas is located in a conventional manner andanesthetized using a local anesthetic. Thereafter, the scrotum ispunctured in accordance with standard procedures, for example, using adissecting forceps, and expanded to allow insertion of either an“excising clamp” or “excising hook” of the present invention, i.e.,instruments used to position a vas duct within the coagulating jaws of abipolar electrosurgical device of the present invention, to maintainthat position during coagulation, and thereafter to divide the vas byexcision.

In the context of a first embodiment, the vasectomy method of thepresent invention involves the capture of the vas using one of the novelexcising clamps or hooks of the present invention and the subsequentdelivery of the vas out of the scrotum a sufficient distance to allowthe arcuate jaws of an improved bipolar coagulating device described indetail herein to be positioned around the hook or clamp. In the contextof the present invention, the tissue is secured between the angularlyoffset, U-shaped cutting jaws of a coagulating device such asexemplified in FIG. 25 and a brief pulse of radio frequency (RF) energy,on the order of 10 to 20 seconds, is supplied to the jaws so as tothermally coagulate portions of the vas between the arcuate jawportions. When coagulation is complete, the excising clamp or hook ismoved downward, upward, or at an angle relative to the U-shaped jaws ofthe coagulating device so that the portion of the vas captured within aninterior surface of the clamp or hook is excised. Excision isaccomplished by the cooperative action of the cutting edges on the jawsof the improved coagulating device and the sharp edges on the excisingclamp or hook. Sealing of the duct, sealing of the sheath, and dividingof the vas are all accomplished in two simple steps that do not requiresurgical skill. Thus, the opportunity for hematoma creation isdramatically reduced.

In the context of an alternative embodiment, the vasectomy method of thepresent invention avoids the need for dissecting the vas from thescrotum. In this alternative method, after the duct is isolated in afold of scrotal tissue, an excising clamp of the present invention isapplied to the fold medial to the duct so as to maintain the position ofthe duct. Once again, the arcuate jaws of a bipolar coagulating devicein accordance with the present invention are then positioned around theclamp so as to compress an arcuate region of tissue between the jaws.This arcuate region contains a portion of the duct positioned within aportion of the fold of scrotal tissue by the excising clamp. Thisarcuate region is then coagulated by means of the RF energy supplied tothe jaws by an electrosurgical generator. When coagulation is complete,the excising clamp is displaced upward, downward, or angularly relativeto the jaws so as to excise the central uncoagulated tissue portionbound by the arcuate coagulated region clamped between the jaws of thecoagulating device. Excision is accomplished by interaction betweencutting edges formed on the jaws of the coagulating device and cuttingedges formed on the jaws of the clamp.

As noted above, the present invention is one aspect relates to theprovision of a variety of novel surgical instruments suitable for use inconnection with the above-mentioned vasectomy methods and improvedbipolar coagulating device, more particularly in the form of novelexcising hooks and clamps adapted and suitable for isolating andexcising a portion of the vas deferens targeted for removal.

In one aspect, the surgical instrument provided by the present inventionis an excising hook that resembles a shepherd's crook, as exemplified inFIG. 37. In a preferred embodiment, the excising hook is composed of anelongate shaft having a thickened proximal portion and a narrowed distalend that curves back on itself to form a circular hook. In a preferredembodiment, the circular hook is formed of suitable dielectric materialand is sized to slidably fit within the U-shaped jaws of the bipolarcoagulating device of the present invention. Likewise, the interiorsurfaces of the hook are suitably sharpened so as to cooperate with thecutting jaws of the bipolar coagulating device to thereby enable removalof a portion of uncoagulated tissue containing an excised length of thevas duct.

In another aspect, the surgical instrument provided by the presentinvention is an excising clamp in the form of a pair of eyelet forceps,such as exemplified in FIG. 11, that includes a proximal handle portionprovided with a pair of “finger grips” or “finger holes” that drive apair of hinged arms that, in turn, define the longitudinal axis of thedevice, and a ratchet mechanism that enables the hands-free maintenanceof the arms, and their respective distal tissue-gripping portions, in alocked configuration. Disposed distally along the respective arms, pasta pivoting hinge, the tissue-gripping portions of this novel, excisingclamp comprise a pair of mating semi-circles that together circumscribea small hole or eyelet that, in operation, becomes disposed about theportion of the vas duct being excised. As noted above, the distal endtissue-gripping portions are provided with sharpened interior edges thatenable removal of an uncoagulated vas tissue through cooperative actionwith the cutting jaws of the bipolar coagulating device as describedabove.

In yet a further aspect, the surgical instrument provided by the presentinvention is an excising clamp in the form of a slidable assembly asillustrated in FIG. 57. In a preferred embodiment, the slidable clampassembly is composed of two pieces, namely an elongate generallyU-shaped clamp body and a slidable control ring, assembled into a singleunit that is suitable for isolating and excising an uncoagulated portionof a vas duct. In the context of the present invention, the elongateclamp body is made up of a proximal handle portion that, proceedingdistally, splits for form a pair of elongate movable pincer arms thattake the form of two relatively parallel intermediate portions (upperand lower) that, in turn, terminate in opposed distal portions (upperand lower), each of which is provided a distal-most portion that takesthe form of a symmetrically opposed jaw. Each opposed jaw is a mirrorimage of the other, or has an otherwise form complementary to the other,and includes a sharp distal tip projecting towards an interior surfaceof the assembly.

In a particularly preferred embodiment, the elongate clamp body furtherincludes a pair of proximal stops, a first positioned along the exteriorsurface of the upper intermediate portion and a second positioned at anequivalent point along the exterior surface of the lower intermediateportion, and a pair of distal stops, a first positioned along theexterior surface of the upper distal portion and a second positioned atan equivalent point along the exterior surface of the lower distalportion, such that the spacing between the upper proximal and distalstops is identical to the spacing between the lower proximal and distalstops.

The afore-mentioned slidable control ring is provided with a centralopening that allows it to be disposed about the periphery of theelongate body and slide along the spacing between respective proximaland distal stops. When the slidable control ring is positioned adjacentthe proximal stops, in a proximal-most position, the opposed upper andlower distal jaws remain in the “open” (unclamped) configuration.However, distal movement of the slidable control ring forces the upperand lower distal portions to deflect inward, moving the respective sharpdistal tips toward contact. When the slidable control ring encountersthe distal stops, it arrives at a distal-most position in which thedistal portions of the opposed distal jaws meet, i.e., are moved intoclose proximity, or optionally in contact close form a “closed”(clamped) configuration.

In a preferred embodiment, both the excising clamp body and slidablecontrol ring are formed of a suitable dielectric material, preferablyfrom a polymeric material by injection molding or other suitableprocess.

In yet another aspect, the surgical instrument provided by the presentinvention is forceps-like clamp as exemplified in FIG. 86. Similar tothe eyelet clamp described above, this excising clamp resembles a pairof scissors or forceps, including a proximal handle portion providedwith a pair of “finger grips” or “finger holes” that drive a pair ofhinged blades that define the longitudinal axis of the device and aratchet mechanism that enables the hands-free maintenance of the blades,and their respective distal jaw portions, in a locked configuration.Disposed distally along the respective blades, past a pivoting hinge,the jaws of this alternate excising clamp are preferably defined by tworelatively parallel, planar, and laterally opposed portions (upper andlower), each of which is provided with a distal-most vertically opposedportion (upper and lower) that is relatively perpendicular to thelongitudinal axis of the device. Upper and lower laterally opposedportions comprise symmetrical mirror images; likewise, upper and lowervertically opposed portions are also symmetrically disposed. In thecontext of the present invention, pivoting the hinged blades brings theupper and lower vertically opposed portions into contact, such thattheir respective terminal surfaces come into contact to form a sharpcutting edge. In the context of the present invention, the respectiveterminal surfaces (and corresponding cutting edges) may be planar,mirror-image serrated or complementary serrated. As in previouslydescribed embodiments, the sharpened surfaces of the excising clampcooperate with the cutting jaws of the bipolar coagulating device tothereby enable removal of a portion of uncoagulated tissue containing anexcised length of the vas duct.

As noted above, the present invention is characterized by substantialadvantages not found in conventional methods and devices. For example,by avoiding direct dissection and resulting bleeding, the presentinvention is able to minimize or preferably eliminate the risk for thedevelopment of massive hematomas and swelling. In addition, the presentinvention allows for the separation of the vas deferens in such a mannerthat it is virtually impossible for the ends of the vas deferens tocontact each other and rejoin. Also, as compared to vasectomy methodscurrently available, the inventive procedure utilizes significantlyfewer surgical steps and thereby reduces the opportunity forcomplications. The inherent simplicity of the disclosed procedures andassociated instruments simplifies training and allows clinicians withlimited experience to master their use. Moreover, the procedures of thepresent invention minimize or even avoid exposure to bodily fluids,which, in turn, significantly reduces risks of transmission ofblood-born diseases, such a HIV and Hepatitis, to performing clinicians.

These and other objectives can be accomplished by the invention hereindisclosed. Further objects and features of the invention will becomemore fully apparent when the following detailed description is read inconjunction with the accompanying figures and examples. To that end, itis to be understood that both the foregoing summary of the invention andthe following detailed description are of a preferred embodiment, andnot restrictive of the invention or other alternate embodiments of theinvention. In particular, while the invention is described herein withreference to a number of specific embodiments, it will be appreciatedthat the description is illustrative of the invention and is notconstructed as limiting of the invention. In addition, regarding thespecific objectives recited above, it will be understood by thoseskilled in the art that one or more aspects of this invention can meetcertain objectives, while one or more other aspects can meet certainother objectives. Each objective may not apply equally, in all itsrespects, to every aspect of this invention. As such, the objectivesherein can be viewed in the alternative with respect to any one aspectof this invention.

BRIEF DESCRIPTION OF THE FIGURES

Various aspects and applications of the present invention will becomeapparent to the skilled artisan upon consideration of the briefdescription of figures and the detailed description of the presentinvention and its preferred embodiments that follows:

FIG. 1 depicts a first step in a prior art No Scalpel Vasectomy (NSV)procedure in which a vas duct is located in a fold of scrotal tissue.

FIG. 2 depicts a subsequent step in the prior art NSV procedure in whichthe vas duct is isolated in a fold of scrotal tissue using a ringedclamp.

FIG. 3 depicts a subsequent step in the prior art NSV procedure in whichan opening is formed in the scrotum and a portion of a vas duct in itssurrounding sheath is extracted from the scrotum.

FIG. 4 depicts a subsequent step in the prior art NSV procedure in whichthe vas sheath is stripped back from the vas duct in preparation forocclusion.

FIG. 5 depicts a subsequent step in the prior art NSV procedure in whicha first side of the hemi-dissected vas duct is coagulated using acautery.

FIG. 6 depicts a subsequent step in the prior art NSV procedure in whicha second side of the hemi-dissected vas duct is coagulated using acautery.

FIG. 7 depicts the vas duct after subsequent removal of the portionmedial to the dissections in the prior art NSV procedure, with the endof the prostate leg ligated and the suture left untrimmed.

FIG. 8 depicts the site subsequent to FIG. 7, wherein the ends of thevas enclosed in the sheath are returned to the scrotum with the leg ofthe ligating suture extending from the puncture in the scrotum.

FIG. 9 depicts the site subsequently to FIG. 8, with the end of theprostate leg of the vas duct secured outside of the vas sheath so as toestablish fascial interposition.

FIG. 10 depicts the site at completion of occlusion of the duct via theprior art NSV procedure in which the ends of the duct returned to thescrotum.

FIG. 11 is a perspective view of an excising clamp of the presentinvention.

FIG. 12 is a side elevational view of the clamp of FIG. 11.

FIG. 13 is an expanded view of the clamp of FIG. 11 at location A.

FIG. 14A is an expanded view of the clamp of FIG. 12 at location B.

FIG. 14B is an expanded sectional view of the objects of FIG. 14A atlocation A-A.

FIG. 15 is an expanded plan view of the distal portion of the clamp ofFIG. 11.

FIG. 16 is a plan view of a bipolar electrosurgical device of avasectomy system of the present invention.

FIG. 17 is a side elevational view of the objects of FIG. 16.

FIG. 18 is a perspective view of the objects of FIG. 16.

FIG. 19A is an expanded view of the objects of FIG. 16 at location B.

FIG. 19B is an expanded sectional view of the objects of FIG. 19A atlocation A-A.

FIG. 20 is an expanded view of the objects of FIG. 18 at location A.

FIG. 21 is an expanded side elevational view of the distal portion ofthe bipolar electrosurgical device of FIG. 16 with the device in anopen, unclamped condition.

FIG. 22 is a distal perspective view of the objects of FIG. 21.

FIG. 23 is a proximal perspective view of the objects of FIG. 21.

FIG. 24 is an expanded view of the objects of FIG. 22 at location D.

FIG. 25 is an expanded view of the objects of FIG. 23 at location E.

FIG. 26 depicts a surgical system including the bipolar electrosurgicaldevice of FIG. 16 connected to a suitable electrosurgical generator withoptional foot pedal connected thereto for activation of the generator.

FIG. 27A is a perspective diagrammatic view of an elongate tissueelement captured within the excising clamp of FIG. 11, and clampedbetween the jaws of the bipolar electrosurgical device of FIG. 16 asduring use.

FIG. 27B is an expanded view of the objects of FIG. 27A at location A.

FIG. 27C is a plan view of the objects of FIG. 27A.

FIG. 27D is an expanded view of the objects of FIG. 27C at location B.

FIG. 27E is an expanded sectional view of the objects of FIG. 27D atlocation B-B.

FIG. 27F depicts the objects of FIG. 27E, wherein RF energy is appliedso as to coagulate tissue between the jaws of the electrosurgicaldevice.

FIG. 27G is a perspective view of the objects of FIG. 27F, wherein theexcising clamp has been moved downward so as to remove a portion of theelongate tissue element.

FIG. 27H is an expanded view of the objects of FIG. 27G at location A.

FIG. 27I is a plan view of the objects of FIG. 27G

FIG. 27J is an expanded view of the objects of FIG. 27I at location B.

FIG. 27K is an expanded sectional view of the objects of FIG. 27J atlocation A-A.

FIG. 27L is a sectional view of the elongate tissue element aftercoagulation and excision as previously described.

FIG. 27M is a perspective view of the elongate tissue element of FIG.27L.

FIG. 28A is a diagrammatic plan view of a portion of a scrotum with avas deferens contained therein.

FIG. 28B is a perspective view of the objects of FIG. 28A.

FIG. 29A is a plan view of an excising clamp of the present inventioncapturing the vas deferens of FIG. 27 inside the scrotum of FIG. 27.

FIG. 29B is an expanded view of the objects of FIG. 29A at location A.

FIG. 30A depicts the objects of FIG. 29A with the vas duct deliveredfrom the scrotum.

FIG. 30B is an expanded view of the objects of FIG. 30A at location A.

FIG. 31A depicts the objects of FIG. 30A with the captured vas ductclamped between the jaws of the bipolar coagulating device of thevasectomy system of the present invention.

FIG. 31B is an expanded view of the objects of FIG. 31A at location A.

FIG. 32A is a perspective view of the coagulated vas duct clampedbetween the jaws of the bipolar device with an uncoagulated portion ofthe duct removed by the excising clamp.

FIG. 32B is a side elevational view of the objects of FIG. 32A.

FIG. 33A is a plan view of the scrotum and coagulated vas duct afterremoval of the bipolar coagulating device.

FIG. 33B is a perspective view of the objects of FIG. 33A.

FIG. 34 depicts the site after the vas duct is returned to the scrotum.

FIG. 35 is a plan view of an excising hook of the present invention.

FIG. 36 is a side elevational view of the objects of FIG. 35.

FIG. 37 is a perspective view of the objects of FIG. 35.

FIG. 38 is an expanded view of the objects of FIG. 36 at location A.

FIG. 39 is an expanded view of the objects of FIG. 37 at location B.

FIG. 40 is a plan view of a vas duct portion within a portion ofscrotum.

FIG. 41 is a perspective view of the objects of FIG. 40.

FIG. 42 is a plan view depicting the vas duct and scrotum portion,wherein the duct portion is captured in the excising hook of FIG. 35.

FIG. 43 is an expanded view of the distal portion of the objects of FIG.42.

FIG. 44 is a side elevational view of the objects of FIG. 43.

FIG. 45 is a perspective view of the objects of FIG. 43.

FIG. 46 is a side elevational view of the objects of FIG. 42, wherein aportion of the vas duct has been delivered from the scrotum.

FIG. 47 is an expanded view of the distal portion of the objects of FIG.46.

FIG. 48 is a plan view of the objects of FIG. 46.

FIG. 49 is an expanded view of the distal portion of the objects of FIG.48.

FIG. 50 is a perspective view of the objects of FIG. 46.

FIG. 51 is an expanded view of the distal portion of the objects of FIG.50.

FIG. 52 is a side elevational view of the objects of FIG. 46, furtherwherein the vas duct portion external to the scrotum is clamped betweenthe jaws of a bipolar coagulating device.

FIG. 53 is an expanded view of the distal portion of the objects of FIG.52.

FIG. 54 is a plan view of the objects of FIG. 52.

FIG. 55 is an expanded view of the distal portion of the objects of FIG.54.

FIG. 56 is a side elevational view of the objects of FIG. 52, furtherwherein an uncoagulated portion of the vas duct has been removed by theexcising hook.

FIG. 57 is a plan view of an alternate embodiment for an excising clampbody in accordance with the present invention.

FIG. 58 is a side elevational view of the objects of FIG. 57.

FIG. 59 is a perspective view of the objects of FIG. 57.

FIG. 60 is an expanded view of the objects of FIG. 58 at location A.

FIG. 61 is an expanded view of the objects of FIG. 59 at location B.

FIG. 62 is a perspective view of an excising clamp ring in accordancewith the present invention.

FIG. 63 is an axial view of the objects of FIG. 62.

FIG. 64 is a side elevational view of the objects of FIG. 62.

FIG. 65 is a plan view of an excising clamp in accordance with thepresent invention, formed of the clamp body of FIG. 57 and the clampring of FIG. 62 with the clamp in a first, open/unclamped condition.

FIG. 66 is a side elevational view of the objects of FIG. 65.

FIG. 67 is a perspective view of the objects of FIG. 65.

FIG. 68 is a plan view of the alternate excising clamp of FIG. 65 in asecond closed/clamped condition.

FIG. 69 is a side elevational view of the objects of FIG. 68.

FIG. 70 is a perspective view of the objects of FIG. 68.

FIG. 71 is an expanded view of the objects of FIG. 69 at location A.

FIG. 72 is a plan view of a portion of a scrotum with a vas duct locatedin a fold thereof.

FIG. 73 is a perspective view of the objects of FIG. 72.

FIG. 74 is a perspective view of the alternate excising clamp of FIG. 65applied to the objects of FIG. 72 so as to maintain the position of thevas duct in the fold of scrotal tissue.

FIG. 75 is an expanded view of the objects of FIG. 74 at location A.

FIG. 76 is a plan view of the scrotum and clamp of FIG. 75 positionedwithin the jaws of the electrosurgical device of FIG. 16.

FIG. 77 is an expanded view of the objects of FIG. 76 at location A.

FIG. 78 is a perspective view of the objects of FIG. 76.

FIG. 79 is an expanded view of the objects of FIG. 78 at location B.

FIG. 80 is a perspective view of the objects of FIG. 76 wherein theexcising clamp has been displaced downward so as to excise a portion ofthe vas duct.

FIG. 81 is an expanded view of the objects of FIG. 80 at location B.

FIG. 82 is an expanded view of the objects of FIG. 81 at location C.

FIG. 83 is a side elevational view of the objects of FIG. 82.

FIG. 84 is a plan view of the treatment site containing the occludeddivided vas duct contained in a region of coagulated scrotal tissue.

FIG. 85 is a perspective view of the objects of FIG. 84.

FIG. 86 is a perspective view of yet another alternate embodiment for anexcising clamp in accordance with the present invention in a closed(clamped) condition.

FIG. 87 is an expanded view of the objects of FIG. 86 at location A.

FIG. 88 is a side elevational view of the objects of FIG. 86.

FIG. 89 is an expanded view of the objects of FIG. 88 at location C.

FIG. 90 is a plan view of the objects of FIG. 86.

FIG. 91 is an expanded view of the objects of FIG. 90 at location D.

FIG. 92 is a perspective view of the alternate excising clamp of FIG. 86in the open (unclamped) condition.

FIG. 93 is a side elevational view of the objects of FIG. 92.

FIG. 94 is an expanded view of the objects of FIG. 92 at location A.

FIG. 95 is an expanded view of the objects of FIG. 93 at location B.

FIG. 96 is a side elevational view of an excising clamp of the presentinvention analogous to that depicted in FIG. 86 in which the jaws of thedistal clamping portion (depicted in the closed (clamped) condition) aremodified to include mirror-image serrations.

FIG. 97 is a perspective view of the alternative excising clamp of FIG.96 in which the modified jaws are depicted in the open (unclamped)condition.

FIG. 98 is a side elevational view of another excising clamp of thepresent invention analogous to that depicted in FIG. 86 in which thejaws of the distal clamping portion (depicted in the closed (clamped)condition) are modified to include complementary serrations.

FIG. 99 is a perspective view of the alternate excising clamp of FIG. 98in which the modified jaws are depicted in the open (unclamped)condition.

FIG. 100 is a side elevational view of the distal portion of yet anotherexcising clamp of the present invention analogous to that depicted inFIG. 86 in which the jaws of the distal clamping portion (depicted inthe closed (clamped) condition) are modified to include complementarycylindrical surfaces.

FIG. 101 is a perspective view of the alternate excising clamp of FIG.100 in which the modified jaws are depicted in the open (unclamped)condition.

FIG. 102 is a side elevational view of yet another excising clamp of thepresent invention analogous to that depicted in FIG. 86 in which thejaws of the distal clamping portion (depicted in the closed (clamped)condition) are modified to include complementary beveled surfaces.

FIG. 103 is an expanded view of the objects of FIG. 102 at location D.

FIG. 104 is a sectional view of the objects of FIG. 103 at location A-A.

FIG. 105 is a perspective view of the objects of FIG. 102 with themodified jaws of the clamp in an open (unclamped) condition.

FIG. 106 is an expanded view of the objects of FIG. 105 at location E.

FIG. 107 is a perspective view of the clamp of FIG. 2 positioned on ascrotum when coagulation of the site is completed according to theprinciples of the present invention.

FIG. 108 is an expanded view of the objects of FIG. 107 at location A.

FIG. 109 is a perspective view of yet another excising clamp of thepresent invention analogous to that depicted in FIG. 86 in which thedistal clamping portion (with jaws depicted in the open (unclamped)condition) is modified to include low included angle edges.

FIG. 110 is an expanded view of the objects of FIG. 107 at location F.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

Before the present materials and methods are described, it is to beunderstood that this invention is not limited to the specific devices,systems, methodologies or protocols herein described, as these may varyin accordance with routine experimentation and optimization. It is alsoto be understood that the terminology used in the description is for thepurpose of describing the particular versions or embodiments only, andis not intended to limit the scope of the present invention which willbe limited only by the appended claims. Accordingly, unless otherwisedefined, all technical and scientific terms used herein have the samemeaning as commonly understood by one of ordinary skill in the art towhich the present invention belongs. However, in case of conflict, thepresent specification, including definitions below, will control.

Unless otherwise defined, all technical and scientific terms used hereinhave the same meaning as commonly understood by one of ordinary skill inthe art to which this invention belongs. However, in case of conflict,the present specification, including definitions, will control.Accordingly, in the context of the present invention, the followingdefinitions apply:

The words “a”, “an” and “the” as used herein mean “at least one” unlessotherwise specifically indicated. Thus, for example, reference to an“opening” is a reference to one or more openings and equivalents thereofknown to those skilled in the art, and so forth.

As used herein, the noted directional terms relate to a human body in astanding position. For instance, “up” refers to the direction of thehead, “down” refers to the direction of the feet. Likewise, herein, the“vertical” direction is parallel to the axis of the body and the“horizontal” direction is parallel to the floor. In a similar fashion,the term “lateral” refers to the direction extending away from thecenter of the body whereas “medial” refers to a direction extendingtoward the center of the body.

In the context of the present invention, the term “proximal” refers tothat end or portion of a device or instrument which is situated closestto the body of the subject when the device is in use. Accordingly, theproximal end of an excising clamp or bipolar electrosurgical device ofthe present invention includes the handle portions.

In the context of the present invention, the term “distal” refers tothat end or portion of a device or instrument that is situated farthestaway from the body of the subject when the device is in use.Accordingly, the distal end of an excising clamp of the presentinvention includes the jaw components.

In the context of the present invention, the term “arcuate” is usedherein to describe shapes forming or resembling an arch. It is usedinterchangeably with its synonym, arciform.

In the context of present invention reference invention, the terms“coagulated” or “cauterized” are interchangably used to describe atreated area of tissue. As used herein, coagulated or cauterized tissueis tissue that through the application of RF energy and pressure hasbeen dessicated and fused to eliminate the flow of blood or otherfluids.

In the context of the present invention, the term “convex” refers to asurface or boundary that curves outward, as the exterior of a sphere.Conversely, the term “concave” refers to a surface or boundary thatcurves inward, as to the inner surface of a sphere, or is hollowed orrounded inward like the inside of a bowl. Herein, the area of unclampedscrotal tissue defined by the U-shaped jaws of the bipolar coagulatingdevice and the arcuate area of clamped scrotal tissue contained thereinis referred to as convex in shape.

In the context of the present invention, the terms “vas”, “duct”, “vasduct” are used interchangeably and refer to the vas deferens, and mayinclude the vas sheath as well. The terms “pure duct” or “pure vas”refer to the duct only.

Devices of the present invention are formed from a dielectric materialand are configured for excision as well as for clamping tissue orcapturing a vas duct. These devices, hereafter referred to as “excisionclamps” or “excision hooks” in methods of the present invention are usedto position a vas duct within the jaws of the coagulating device, tomaintain that position during coagulation, and thereafter to divide thevas by excision.

As noted above, the present invention is characterized by substantialadvantages not found in conventional methods and devices. For example,by avoiding direct dissection and resulting bleeding, the presentinvention is able to eliminate the risk for development of massivehematomas and swelling. In addition, the present invention allows forthe separation of the vas deferens in such a manner that it is virtuallyimpossible for the ends of the vas deferens to contact each other andrejoin. Also, the number of steps in the procedure is much less than forother current vasectomy techniques thereby reducing opportunities forcomplications. The inherent simplicity of the disclosed procedure andassociated instruments simplifies training and allows clinicians withlimited experience to master their use. Moreover, the procedures of thepresent invention avoid exposure to bodily fluids, which, in turn,minimizes risks of transmission of blood-born diseases, such a HIV andHepatitis, to performing clinicians.

Although methods and materials similar or equivalent to those describedherein can be used in the practice or testing of embodiments of thepresent invention, the preferred methods, devices, and materials aredepicted in the accompanying figures and described hereinafter. However,the embodiments described herein are merely intended to illustrate theprinciples of the invention. Those skilled in the art will recognizethat variations and modifications may be made to the embodiments withoutchanging the principles of the invention herein disclosed. Accordingly,the accompanying figures, described in detail below that depict aspectsof the invention are in no way intended to limit the scope of thepresent invention.

EXAMPLES

The most common method of vasectomy currently practiced is theno-scalpel vasectomy (NSV) in which the vas deferens is delivered fromthe scrotum via one or two openings formed by puncturing the scrotum andthen expanding the opening(s). Steps of a standard prior-art NSV whereina vas duct is occluded are depicted in FIGS. 1 through 10. In FIG. 1, avas duct 20 is located in scrotum 10 using a standard three-fingertechnique. Thereafter, a local anesthetic is injected at the site. Duct20 is then isolated in a fold of scrotum 10 using a ringed forceps 4 asshown in FIG. 2. The scrotum is then punctured using a dissectingforceps and the opening expanded sufficiently to allow the surgeon todeliver a portion 26 of vas duct 20 as depicted in FIG. 3. Dissectingforceps 6 are then used to puncture vas sheath 29 and then strip sheath29 back to expose duct portion 28 as shown in FIG. 4. In FIGS. 5 and 6,duct portion 28 is hemi-dissected into abdominal and testicularportions, after which the distal element of an electrocautery 7 isinserted into the lumens of the respective portions and activated so asto form scar tissue in the lumens and thereby occlude them. Thereafter,as shown in FIG. 7, a suture 8 is applied to the abdominal leg of theseparated duct portion 28. Next, vas sheath 29 with the testicularportion of separated duct 28 are drawn back into scrotum 10 with suture8 extending through the opening in sheath 29 and the opening in scrotum10 as shown in FIG. 8. In FIG. 9, suture 8 is used to draw duct 28 andsheath 29 out of scrotum 10, and to draw the abdominal side occluded endof duct 28 out of sheath 29, whereupon suture 10 is tied around aportion of sheath 28 and duct 29 as depicted in FIG. 9. Placing suture 9in this manner permanently places a wall of sheath 29 between thedivided occluded ends of duct 28 so as to provide an additional barrierto reuniting of the divided ends. FIG. 10 depicts the site withoccluded, divided vas duct 20 returned to scrotum 10 with the duct endsbeing separated by fascial interpositioning.

As discussed in greater detail above, the NSV procedure has multiplesteps and requires extensive surgical skills. Completing the proceduregenerally requires twenty minutes or more. If the surgeon fails tonotice and address any bleeders, hematomas may result. Because thescrotum is a flexible expandable vessel, these hematomas may becomemassive, resulting in pain and anxiety for the patient. In all cases itis necessary for the patient to restrict activities following theprocedure, frequently for a week or more.

Devices and methods of the present invention enable a clinician toperform an NSV procedure in less time and with a decreased likelihood ofcomplications. To that end, in the current NSV technique, occluding ofthe duct, dividing of the duct, and creating the fascial interpositionare accomplished in three separate steps. However, using devices andmethods of the present invention, these three tasks may be accomplishedin a single step. Namely, the vas duct and its surrounding sheath arecaptured in an excising clamp or excising hook of the present inventionand delivered from the scrotum. While remaining contained and isolatedin the clamp or hook, the duct and its surrounding sheath are graspedbetween the jaws of a modified version of a bipolar coagulating devicesuch as described in U.S. Pat. Nos. 8,220,464 and 8,561,615, thecontents of which are enumerated and incorporated above, and sealedusing RF energy. Thereafter, the duct is divided by excision using oneof the novel excising clamps or excising hooks of the present inventionbefore releasing the jaws of the coagulating device. In contrast withthe conventional art-accepted NSV technique, stripping of the vassheath, occlusion of the duct by cautery or ligation, and creatingfascial interpositioning of the sheath as discrete steps by the surgeonare not required. Thus, as less surgical skill is required, theprocedure may be performed by a non-surgeon on the medical staff, forexample, a nurse, nurse practitioner, or physician's assistant.

The inventive method and novel excising clamps and hooks are nowdescribed. To that end, a first iteration of an excising clamp 100 ofthe present invention is depicted in FIGS. 11 through 15. Excising clamp100 has a first element 102 with a proximal handle portion 104 and adistal portion 106, and a second element 122 with a proximal handleportion 124 and a distal portion 126, elements 102 and 122 beingrotatably affixed by element 101. First element 102 has formed near itsproximal end first ratchet portion 118. Second element 122 has formednear its proximal end second ratchet portion 138. Ratchet elements 118and 138 cooperatively, when engaged, maintain closure and tension ofclamp 100 during use. Distal portion 106 of first element 102 has formedat its distal end arcuate first jaw 108. Distal portion 126 of secondelement 120 has formed at its distal end arcuate second jaw 128. When inthe closed position, inner surfaces 110 and 130 of jaws 108 and 128respectively circumscribe eyelet 103 proximal to jaws 108 and 128.Laterally opposed planar surfaces 115 of lower jaw 108 and 135 of upperjaw 128 intersect with surfaces 110 and 130 respectively to form sharpedges perimetral to opening 103 (see FIG. 14B). When viewed in planview, as in FIG. 15, jaws 108 and 128 together with proximally adjacentportions of distal portions 106 and 126 have width 116. Excising clamp100 is formed of a suitable dielectric material. In a preferredembodiment, clamp 100 is formed of a polymeric material formed byinjection molding.

Excising clamp 100 is configured for removal of an uncoagulated tissueportion by cooperative action of clamp 100 and the jaws of a bipolarcoagulating device configured for this purpose. The bipolar coagulatingdevice (handpiece) 400 of the present invention depicted in FIGS. 16through 20 with the jaws in a first, clamped position is substantiallysimilar to the equivalent electrosurgical device described in U.S. Pat.No. 8,561,615 and operates by an analogous procedure. To wit, bipolarhandpiece 400 has an upper handle assembly 402 with a proximal handleportion 404 and a distal portion 406 wherein is mounted lower jaw 408.Handpiece 400 has a lower handle assembly 422 with a proximal handleportion 424 and a distal portion 426 wherein is mounted upper jaw 428.Upper handle assembly 402 and lower handle assembly 422 are rotatablyjoined by element 401. Lower handle assembly 422 has located adjacent toits proximal end ratchet element 430 that, in cooperation with downwardextending proximal portion 410 of upper handle assembly 402 maintainsthe clamping force of jaws 408 and 428, portion 432 of ratchet element430 limiting the interjaw force that can be applied. Bipolar cable 440is connected at its proximal end to the bipolar outputs of a suitableelectrosurgical generator, and at its distal end, via wires 442 and 444to upper jaw 428 and lower jaw 408 respectively such that RadioFrequency (RF) energy from the generator is conducted to jaws 408 and428 so as to coagulate tissue clamped therebetween. In a preferredembodiment, RF energy from the electrosurgical generator is modulatedaccording to an algorithm in the generator for maximal coagulation oftissue between the jaws.

As best seen in the close-up views of FIGS. 18-20 and 22-23, upper 428and lower 408 jaws are mirror images, each including a proximal portionthat attaches to the distal end of the handpiece and a distal portionthat is off-set from the longitudinal axis defined by the handpiece,preferably disposed at an angle of about 45 degrees. The angular offsetaffords the surgeon better visibility and access to the target surgicalsite. As best seen in FIG. 19A, upper jaw 428 has a “U” shape with acentral slot 429 of width 480, with lower jaw 408 having a correspondingshape so that tissue may be clamped between the U-shaped jaw portions ofjaws 408 and 428.

Referring now to FIG. 19B, the U-portions of jaws 408 and 428 haveradiused outer circumferential portions 403 and 423 respectivelyadjacent to their clamping surfaces to prevent cutting of tissue clampedbetween jaws 408 and 428. Edge 405 formed by the intersection of surface407 of jaw 408 with the circumferential surface of slot 409 is sharp soas to allow edge 405 to cut tissue. Edge 425 formed by the intersectionof surface 427 of jaw 428 with the circumferential surface of slot 429is also sharp so as to allow edge 425 to cut tissue. Width 480 of slots409 and 429 is slightly greater than width 116 of distal portions 106and 126 of excising clamp 100 (see FIG. 15). In a preferred embodiment,each offset central slot defined by each “U-shaped” distal portion isapproximately 1-3 mm in width and is further provided with an interiorsharp edge, radiused lateral portions, and a relatively planar exteriorsurface; when brought into contact, in a closed configuration, therespective upper and lower sharp edges together form the cutting surfaceof the surgical jaws. The distal portion of handpiece 400 with handpiece400 in its second (unclamped) position is depicted in FIGS. 21 through25. Jaws 408 and 428 are formed of a stainless steel or other suitablemetallic material.

FIG. 26 depicts bipolar coagulating device 400 connected by cable 440 tothe bipolar outputs of electrosurgical generator 13 for use. In thedepicted preferred embodiment, generator 13 is activated by foot pedal15. While not shown, it is understood that electrosurgical generator maybe powered by alternating current, for example, via a conventional wallsocket, or alternatively may be powered by direct current, for example,by means of an included rechargeable power source.

In a preferred embodiment, generator 13 monitors the impedance of thetissue between jaws 408 and 428 of coagulating device 400 duringactivation, the impedance increasing as coagulation of the tissueproceeds. When the impedance reaches a preset value indicating that apredetermined level of coagulation has been reached, generator 13 isautomatically deactivated or, alternatively, an audible signal is givento indicate to the surgeon that coagulation is complete so that thesurgeon may terminate activation. In other embodiments, the surgeondetermines when coagulation is complete and physically deactivates thegenerator by releasing foot pedal 15. In some preferred embodiments,generator 13 has an algorithm that modulates the power output ofgenerator 13 to achieve effective coagulation without charring thetissue. In other embodiments, the power output of generator 13 isdetermined by the surgeon. In still other embodiments the generatormeasures the initial impedance of tissue clamped between jaws 408 and428. If the impedance falls within a predetermined acceptable range, thegenerator may automatically activate after a predetermined time delayand terminate activation when a predetermined impedance value isreached. In these embodiments foot pedal 15 is eliminated.

Excising clamp 100 and coagulating device 400 work together to occlude agenerally tubular tissue structure by means of coagulation and tosubsequently excise a portion of the tissue structure. In use, anelongate tissue structure is captured by clamp 100, locally coagulatedby coagulating device 400, and thereafter a portion of the tissue isexcised by clamp 100. A preferred method of cooperative use of excisingclamp 100 and bipolar coagulating device 400 is hereafter described.

FIGS. 27A through 27E depict an elongate tissue element 70 capturedwithin eyelet 103 of jaws 108 and 128 of clamp 100 (see FIG. 14A). Asbest seen in FIG. 27E, jaws 108 and 128 with tissue element 70 capturedtherein are positioned within slots 409 and 429 of jaws 408 and 428respectively of bipolar coagulating device 400, with jaws 408 and 428clamped on tissue element 70 lateral to jaws 108 and 128 of clamp 100.In FIG. 27F, generator 13 has been activated causing radio frequencyenergy indicated by arrows to flow between jaws 408 and 428 of bipolarcoagulating device 400. This energy flow and pressure applied by jaws408 and 428 causes coagulation of portions 73 of elongate tissue element70 clamped between jaws 408 and 428 of coagulating device 400. When RFenergy is applied, the collagen and elastin in the tissues are reformedby heat and pressure to fuse the walls of the tubular tissue element 70,thereby forming a permanent seal.

In FIGS. 27G through 27K, clamp 100 has been displaced downward relativeto jaws 408 and 428 of coagulating device 400 so as to excise portion 71of tissue element 70. Referring to FIG. 27K, the intersections ofsurface 130 with lateral surfaces 135 form cutting edges on excisingclamp 100 at eyelet 103. Similarly, the intersection of surface 407 withthe surface of slot 409 of jaw 408 forms cutting edge 405 that surroundsslot 409 of coagulating device 400. Portion 71 is excised from elongatetissue element 70 by the cooperative cutting action of the previouslydescribed cutting edges of clamp 100 and coagulating device 400. Jaw 428of coagulating device 400 and jaw 108 of clamp 100 each have cuttingedges symmetrically opposed to those of the opposing jaw on theirparticular device so that excision of portion 71 may alternatively beaccomplished by upward relative movement of clamp 100 relative tocoagulating device 400. Because the cutting edges formed on jaws 408 and428 of coagulating device 400 are planar, and edges of jaws 108 and 128of excising clamp 100 have a curvilinear profile, a shearing actionoccurs as a cutting edge of clamp 100 passes by a cutting edge ofcoagulating device 400. Portion 71 of elongate tissue element 70 is notcoagulated.

FIGS. 27L and 27M depict elongate tissue element 70 at the completion ofthe procedure previously described. Element 70 has been divided and theends created sealed by coagulation. Coagulated regions 73 occlude thelumen, and dividing tubular element 70 by excision of portion 71permanently prevents flow through tubular element 70.

Bipolar tissue sealing and cutting devices are well known in the art.Typical of these is the LigaSure™ Vessel Sealing System by Covidien, Inc(Boulder, Colo.). Therein, a pair of bipolar jaws is used to coagulatetissue clamped between them. When coagulation is complete, a cuttingelement is distally extended in a groove formed in the jaws to dividethe vessel through the middle of the coagulated region. The sealing andexcision method and devices of the present invention differ from thoseof prior art vessel sealing and cutting systems in that a tissue portionis excised to divide the structure, the excised portion being made up ofuncoagulated tissue. Also, excision of the uncoagulated tissue portionis accomplished by a second device, one that is particularly adapted toreceive, isolate and excise a tubular tissue as opposed to by thecoagulating device per se. In the novel methods of the presentinvention, an excising clamp of the present invention excises anuncoagulated tissue portion through a cooperative cutting action betweencutting edges formed on the excising clamp and the jaws of the bipolarcoagulating device. In further contrast to prior art seal and cutdevices, which tend to be poorly suited for vasectomy applications, thenovel methods of the present invention enable delivery of the vas ductfrom the scrotum so that coagulation and separation of the duct can bedirectly observed and avoid the unnecessarily complex and inconvenientmanipulation and exchanging of devices by the surgeon.

Use of devices and methods of the present invention for occluding anddividing by excision a tubular tissue element are hereinafter describedas they relate to performing a vasectomy.

FIGS. 28A and 28B diagrammatically depict a vas duct 20 positionedwithin a fold of scrotum 10. Vas duct 20 is located in scrotum 10 usingthe standard “three-finger” technique used for no scalpel vasectomy(NSV) procedures. Thereafter, a local anesthetic is introduced and anopening formed in scrotum 10 using a dissecting forceps, both in thesame manner as for a standard NSV. Then, as depicted in FIGS. 29A and29B, distal portion of clamp 100 is inserted into scrotum 10 so as tocapture duct 20 in eyelet 103 formed by jaws 108 and 128 of clamp 100(see FIG. 14A). In FIGS. 30A through 31B, excising clamp 100 hasdelivered vas 20 from scrotum 10 with portion 26 of duct 20 retainedwithin eyelet 103 of clamp 100 in the manner previously described usingtubular tissue element 70. Thereafter, jaws 408 and 428 are positionedabout jaws 108 and 128 of clamp 100 as depicted in FIGS. 31A and 31B,portion 26 of duct 20 being clamped between jaws 408 and 428 aspreviously described and shown in FIGS. 27A through 27E using tubulartissue element 70. Radio Frequency energy is then supplied byelectrosurgical generator 130 via cable 440 to jaws 408 and 428 so as tocoagulate portions of portion 26 of vas duct 20 clamped between jaws 408and 428. When coagulation is complete, clamp 100 is moved downwardrelative to coagulating device 400 so as to excise duct portion 27retained within eyelet 103 of clamp 100 as shown in FIGS. 32A and 32B.Jaws 428 and 408 are then unclamped from vas portion 26 and removed.FIGS. 33A and 33B depict scrotum 10 and duct 20 prior to returning thedivided duct 20 to scrotum 10. Coagulated end portions 28 of ductportion 26 occlude the vas duct, and also seal the occluded duct endswithin the coagulated ends of the vas sheath so as to provide fascialinterposition. FIG. 34 depicts vas 20 with occluded coagulated ends 28returned to scrotum 10. The procedure is repeated on the second vas ductto complete the vasectomy. Occlusion of the two ducts may beaccomplished through a single opening or through two openings dependingon the surgeon's preference.

In an alternate embodiment, the procedure of the present invention foroccluding a vas duct may be modified such that the excising clamp 100 isreplaced by an excising hook 200 of the present invention. Referring toFIGS. 35 through 39, excising hook 200 has a proximal handle portion 202and an elongate distal portion 204 with a distal end portion 206. Distalend portion 206 has parallel planar lateral surfaces 212 spaced distance214 apart, distance 214 being slightly less than width 480 of slots 409and 429 of jaws 408 and 428 of bipolar device 400 (see FIG. 19A). Distalhook portion 208 has an inner surface perpendicular to lateral surfaces212 so as to form a sharp edge. Hook 200 is formed of a suitabledielectric material, either polymeric or ceramic. In a preferredembodiment, distal portion 204 is formed of a ceramic material andhandle portion 202 is formed of a polymeric material.

In this alternative method of the present invention for occluding anddividing a vas duct, excising hook 200 and bipolar coagulating device400 are used in the same manner as previously described with respect toexcising clamp 100 and coagulating device 400 except as subsequentlyspecifically described. FIGS. 40 and 41 depict vas duct 20 locatedwithin a fold of scrotum 10, duct 20 being positioned therein and theregion injected with a local anesthetic using standard NSV methods. Anopening is then formed in scrotum 10 proximate to duct 20 using adissecting forceps in the usual manner. Thereafter, as shown in FIGS. 42through 45, distal portion 206 of excising hook 200 is inserted intoscrotum 10 through the opening formed therein and duct 20 is captured indistal hook portion 208. Handle 202 of excising hook 200 is then pivoteddownward and proximal so as to deliver duct 20 from scrotum 10 asdepicted in FIGS. 46 to 51. Portion 26 of vas duct 20 remains capturedwithin hook portion 208 of excising hook 200. Jaws 408 and 428 ofcoagulating device 400 are then positioned about hook portion 208 ofexcising hook 200 and clamped onto portion 26 of vas duct 200 asdepicted in FIGS. 52 through 55. Radio frequency energy supplied to jaws408 and 428 of coagulating device 400 by electrosurgical generator 13along with pressure applied by jaws 408 and 428 coagulates portions ofduct portion 26 clamped between the jaws in the manner previouslydescribed so as to occlude duct portion 26. After coagulation iscomplete, excising hook 204 is displaced downward relative to jaws 408and 428 of coagulating device 400 so as to excise an uncoagulated ductportion 27 from the coagulated portions of duct portion 26 clampedbetween jaws 408 and 428 to divide duct 20. Excision is accomplishedthrough cooperative action of the cutting edges formed between surface210 and lateral surfaces 212 of excising clamp 200, and the cutting edge403 of jaw 408 (see FIG. 27K). Thereafter jaws 408 and 428 are unclampedfrom the coagulated portions of duct portion 26 and the occludedportions of duct 20 are returned to scrotum 10. The second vas duct isthen occluded in the same manner to complete the procedure.

In NSV methods, including the inventive versions described herein, vasducts are delivered from the scrotum for occlusion and division. In analternate embodiment, the modified vasectomy methods of the presentinvention that utilize the novel devices of the present invention avoidthe need for the vas duct to be delivered from the scrotum, but ratherallow it to remain positioned within a fold of scrotal skin and occludedand divided in situ, without dissection from the scrotum. In thismanner, no openings are formed in the scrotum. Because there is nodissection, hematomas are wholly prevented. Likewise, as no sharpinstruments are used, the risk to the clinician when performing avasectomy on a HIV+ patient is substantially reduced. As with thepreviously described embodiments, excision is accomplished by anexcising clamp of the present invention in cooperation with the jaws ofbipolar coagulating device 400. FIGS. 57 through 61 depict a body 301for an alternate embodiment excising clamp of the present invention.Body 301 has a proximal handle portion 302 and upper and lower distallyextending portions 304. Portions 304 have proximal parallel portions 306whereon are positioned proximal stops 308, distal parallel portions 312with distal stop 313 at their distal ends, and angled portions 310positioned between proximal and distal parallel portions 306 and 312.Distal portions 314 of thickness 316 have distal-most portions formingopposed jaws 318 with symmetrically opposed faces 320, and adjacentsymmetrically opposed faces 322. The edges between surfaces 320 and 322and the laterally opposed faces 315 of distal portions 314 areorthogonal and have minimum edge radii.

Referring now to FIGS. 62 through 64 depicting a control ring 360 for anexcising clamp of the present invention, ring 360 has a central opening362 configured to be slidably received on the proximal parallel portions306 of distally extending portions 304 of body 300.

Excising clamp body 301 and ring 360 are formed of a suitable dielectricmaterial. In a preferred embodiment body 100 and ring 200 are formed ofa polymeric material by injection molding or other suitable process.

Excising clamp 300 of the present invention is depicted in its open(unclamped) position in FIGS. 65 through 67. Ring 360 is positioned onproximal parallel portions 306 of distally extending portions 304 ofbody 301, distal to proximal stops 308. In an unconstrained condition,stops 308 protrude beyond the upper and lower surfaces of opening 362 inring 360, ring 360 being moved distal to stops 308 by deflectingdistally extending portions 304 inward. Surfaces 320 of jaws 318 areseparated by distance 324 in the unclamped condition depicted.

Clamping tissue between opposed surfaces 320 of clamp body 301 isaccomplished by moving ring 360 distally over angled portions 310 ofclamp body 301 so as to deflect distally extending portions 304 towardeach other as depicted in FIGS. 68 to 71. Ring 360 is moved distallyuntil it reaches distal parallel portions 312 encountering distal stop313. In this closed position, opposed faces 320 are in close proximityto each other, or optionally may be in contact.

In a first step of a vasectomy procedure according to methods of thepresent invention, a first vas duct is isolated in a fold of scrotalskin as depicted in FIGS. 72 and 73 wherein duct 20 is located in a foldof scrotal skin 10. In FIGS. 74 and 75, clamp 300 is applied to the foldof scrotal skin 10 with jaws 318 medial to duct 20 so as to maintain theposition of duct 20 in the fold, and ring 360 is advanced to its distalposition so as to close jaws 318 on the tissue. Thereafter, upper andlower jaws 408 and 428 of handpiece 400 are positioned around distalportion 314 of clamp body 301 of clamp 300 and handpiece 400 is closedso as to apply compressive force to the tissue between jaws 408 and 428as shown in FIGS. 76 through 79. The clamping force may be maintained byratchet element 430 of lower handle assembly 422. Subsequently RF energyfrom electrosurgical generator 13 (FIG. 26) is supplied to jaws 408 and428 by wires 442 and 444 and cable 440 so as to coagulate portions ofscrotal skin 10 and vas duct 20 that are compressed between jaws 408 and428. When coagulation is complete, clamp 300 is moved relative to jaws408 and 428 so that the central uncoagulated tissue portion 30containing scrotal skin 10 and a portion of vas duct 20 is removed asdepicted in FIGS. 80 and 81. Tissue portion 30 is removed by cooperativecutting action between an edge of clamp 300 and an edge of lower jaw408. Specifically, the clamp cutting edge is formed by the intersectionof surfaces 320 and 322 with lateral surfaces 315 of the upper distalportion 314 of clamp body 301. The handpiece jaw cutting edge is edge411 of lower jaw 404. As clamp 300 is moved downward relative tocoagulating device or “handpiece” 400 as depicted in FIGS. 80 and 81,initially tissue trapped between surfaces 320 is cut by the portion ofedge 411 of jaw 404 in the distal radius of edge 411 adjacent to surface320 of clamp body 300. Thereafter, as downward motion of clamp 300continues, tissue trapped between the clamp cutting edge formed by theintersection of surface 322 with lateral surfaces 315 of upper distalportion 314 of clamp 300 and the linear portions of edge 411 of lowerjaw 404 is cut. FIGS. 80 and 81 depict handpiece 400 and clamp 300 withthe uncoagulated tissue portion 30 after removal of portion 30.

Referring now to FIGS. 82 and 83, tissue portion 30 contains a segmentof vas duct 20 comprising the duct and sheath wrapped in a portion ofscrotal tissue 10. By examining removed tissue portion 30 undermagnification, the clinician can verify that the procedure wassuccessful through visualization of vas duct segment 20 within removedtissue portion 30.

After coagulation of the site and removal of tissue portion 30, ratchet430 is disengaged so as to remove the clamping pressure from jaws 408and 428 of handpiece 400. The handpiece 400 is then opened and removed.Thereafter the site is as depicted in FIGS. 84 and 85. Region 12contains coagulated scrotal tissue 10 and coagulated vas duct 20.Coagulated region 12 surrounds slot 14 wherein uncoagulated portion 30was previously excised.

Vas duct 20 is coagulated along with its surrounding sheath so toprovide fascial interposition sealing of duct 20 during healing.

In the above described embodiment, excising clamp 300 is moved into aclamped (closed) position by advancing control ring 360 to a distalposition, clamp body 301 having a unitary construction with resilientdistally extending portions 306. However, in other embodiments ofexcising clamps of the present invention, the clamp may be formed of twopivotably joined elements in the manner of clamp 100 (FIGS. 12 through15). Such an alternate embodiment is depicted in FIGS. 86 through 95,wherein excising clamp 700 is formed of elements 740 having proximalportions that form finger holes 742, and whereon are formed ratchetportions 744. Elements 740 are pivotably joined by element 746. Distalto element 746, distal portions 748 of elements 740 have a distal-mostportion 714 of width 716 (FIG. 91) that is slightly less than width 480of slots 429 and 409 of jaws 428 and 408 respectively (see FIGS. 19A and19B). Distal-most portions 714 have at their distal ends jaw portions718 with vertically opposed, planar jaw faces 720. Distal-most portions714 have laterally opposed surfaces 715, and surfaces 722 that areperpendicular to surfaces 715, and that together define distal opening750 of clamp 700. The juncture of laterally opposed surfaces 715 and thedistal surface joining them with vertically opposed surfaces 720 andsurfaces 722 of elements 740 form a cutting edge in the same manner asthe corresponding features of clamp 300. Clamp 700 is used in the samemanner as clamp 300 and performs the same functions.

In use, clamp 700 maintains the position of duct 20 within fold ofscrotal tissue 10 as depicted in FIGS. 74 and 75, with closure of clamp700 being maintained by cooperative action of ratchet features 744 ofelements 740. Thereafter, jaws 408 and 428 of device 400 are positionedaround distal portions 714 of clamp 700 in the same manner as depictedwith portions 314 of clamp 300 in FIGS. 76 through 79. When coagulationis complete, tissue portion 30 (FIGS. 80 and 81) is removed by clamp 700in the same manner as depicted using clamp 300. Cutting edges of distalportions 714 in cooperation with cutting edges of jaws 408 and 428 ofcoagulating device 400 separate tissue portion 30 from the surroundingcoagulated tissue trapped between jaws 408 and 428.

While vertically opposed surfaces 720 of distal portions 714 of clamp700 are depicted as planar, in other alternate embodiments of thepresent invention serrations may be formed on surface to aid inmaintaining the location of jaws 718 when clamping scrotal tissue, andto aid in cutting tissue portion 30 from the surrounding coagulatingtissue. For instance, excising clamp 500, the distal portion of which isdepicted in FIGS. 96 and 97, is identical in all aspects of form andfunction to excising clamp 700 except as specifically subsequentlyherein described. Vertically opposed surfaces 520 of clamp 500 haveformed thereon serrations, the serrations on a first surface 520 being amirror of the serrations on the opposing, second surface 520.

Another embodiment of an excising clamp 600 in accordance with thepresent invention is depicted in FIGS. 98 and 99 and is identical in allaspects of form and function to clamp 700 except as specificallysubsequently described. Vertically opposed surfaces 620 of clamp 600have formed thereon serrations, the serrations on a first surface 520being complementary to the serrations on the opposing, second surface520. Another alternate embodiment excising clamp 800 is identical in allaspects to previously described clamp 700 in form and function exceptthat vertically opposed surfaces 820 are configured as complementarycylindrical surfaces. Indeed, the vertically opposed clamping surfacesof excising clamps of the present invention may be optimized for thedual functions of clamping tissue so as to maintain the position of avas duct in a fold of scrotal skin, and of subsequently excising atissue portion that is confined within the jaws of a coagulating device.These clamping surfaces may be planar, may have serrations formedthereon, may have a cylindrical surface formed thereon, or may have acombination of these features. Cross-sections of these surfaces mayinclude linear, radial or curvilinear shapes. All fall within the scopeof the present invention.

In excising clamps of the present invention previously described herein,opposed surfaces 820 of clamp 800 are indicated as perpendicular tolateral surfaces 815, with surfaces 720 of clamp 700 being perpendicularto lateral surfaces 715, and surfaces 620 of clamp 600 beingperpendicular to lateral surfaces 615. However, in an alternateembodiment of the present invention, low included angle cutting edgesmay be formed on the upper opposed clamping surface to aid in tissuedissection. Referring now to FIGS. 102 through 106 depicting the distalportion of such an alternate excising clamp 900, upper opposed surface920 is not planar like lower opposed surface 920, but rather has formedthereon beveled edges 921 with included angle 919. Beveled edges 921extend around the distal radius of upper opposed surface 920 so that acontinuous cutting edge is formed. Angle 919 is preferably between 10and 80 degrees, and more preferably between 20 and 60 degrees. Excisingclamp 900 may be used in the same manner as those previously hereindescribed, that is, to maintain the position of the vas duct in a foldof scrotal tissue, to provide a guide for positioning of the jaws ofhandpiece 400, and to excise the uncoagulated tissue portion from thesite when coagulation is complete. Because low included angle edges 921are formed on upper opposed surface 920, clamp 900 may optionally beused to excise the uncoagulated tissue portion from the site whencoagulation is complete without cooperative interaction with jaws 408and 428 of device 400. That is, jaws 408 and 428 may be unclamped anddevice 400 may be removed from the site when coagulation is complete.Thereafter, the site is as depicted in FIGS. 107 and 108 wherein clampjaws 1018 are positioned on scrotum portion 10. Uncoagulated tissueportion 19 is surrounded by arcuate coagulated region 12, the opposingsharp inner edges of jaws 408 and 428 creating a sharp margin 17 betweenuncoagulated tissue portion 19 and surrounding coagulated region 12.When clamp 900 is moved downward and proximally edges 921 of upperopposed clamping surface 920 initiate dividing of the tissue alongmargin 17 so that uncoagulated portion 19 is removed from the site.Thereafter the site is as previously depicted in FIGS. 84 and 85. In analternate embodiment, shown in FIGS. 109 and 110, low included angleedges 1023 are formed on a distal portion of surface 1022 of the upperjaw 1014 of clamp 1000 to aid in excising portion 19 from coagulatedregion 12.

INDUSTRIAL APPLICABILITY

All publications mentioned herein are incorporated herein by referencein their entirety. However, nothing herein should be construed as anadmission that the invention is not entitled to antedate such disclosureby virtue of prior invention.

As noted previously herein, the vasectomy device, kit and method forperforming vasectomies of the present invention overcome disadvantagesand deficiencies of conventional vasectomy materials and methods byproviding a rapid, reliable, less invasive male sterilization procedurethat reduces or eliminates negative side effects, including swelling andspontaneous regeneration, and minimizes recovery time and recoveryrestrictions. It further avoids or minimizes the potential for exposureto patient bodily fluids, thereby minimizing the potential fortransmission of blood-borne diseases such as HIV and Hepatitis.

Due to the complications associated with traditional vasectomies buteliminated by the techniques and devices herein disclosed, successfulprocedures have, in the past, required the utilization of skilledexperienced surgeons. However, the vasectomy device and method of theinstant invention minimizes the number of steps and duration of theprocedure, thereby allowing the procedure to be quickly completed byclinicians with minimal training. Moreover, given its simplicity, lessskilled heath care workers can master the procedure in a relativelyshort period of time. This will extend the feasibility of malesterilization to areas of the world where doctors, more particularlyskilled surgeons, are in short supply. For example, the instruments, kitand method of the instant invention may be advantageously used forpopulation control in developing countries.

While the invention has been described in detail and with reference tospecific embodiments thereof, it is to be understood that the foregoingdescription is exemplary and explanatory in nature and is intended toillustrate the invention and its preferred embodiments. Through routineexperimentation, one skilled in the art will readily recognize thatvarious changes and modifications can be made therein without departingfrom the spirit and scope of the invention.

Other advantages and features will become apparent from the claims filedhereafter, with the scope of such claims to be determined by theirreasonable equivalents, as would be understood by those skilled in theart. Thus, the invention is intended to be defined not by the abovedescription, but by the following claims and their equivalents.

What is claimed:
 1. A method for performing a vasectomy comprising thesteps of: a. locating a length of vas deferens within a scrotum; b.dissecting said length of vas deferens from the scrotum; c. placing atissue-capturing distal end of an excising clamp or hook about saidlength of the vas deferens dissected from the scrotum in step (b) so asto temporarily isolate said length of vas deferens; d. providing abipolar device having a proximal handle portion that defines alongitudinal axis of the device and a distal clamping portioncharacterized by a pair of opposingly-faced, upper and lower coagulatingjaws, wherein each of said jaws is (i) movable between open and closedpositions, and (ii) provided with mating inner edges, whereby, when saidjaws are in the closed position and viewed in a plan view, said inneredges engage to define an interior perimeter comprised of (1) a centralslot that is angularly offset from said longitudinal axis and (2) alateral opening sized to permit said distal clamping portion to bepositioned around said tissue-capturing distal end of said excisingclamp or hook that retains said isolated length of vas deferens; e.tightly closing said coagulating jaws about the tissue-capturing distalend of said excising hook or clamp to thereby define (i) a first area ofclamped vas tissue disposed between said closed coagulating jaws and(ii) a convex second area of vas tissue that includes said length of vasdeferens isolated by the tissue-capturing distal end of said excisinghook or clamp; f. activating said bipolar device so as to coagulate saidfirst area of clamped vas tissue; g. sliding the tissue-capturing distalend of said excising clamp or hook relative to the jaws of the bipolardevice in a direction normal to a plane defined by said coagulatingjaws, whereby outer surfaces perimetral to said tissue-capturing distalend of said excising clamp or hook interact with the mating inner edgesof the coagulating jaws of said bipolar device so as to excise some orall of said second area of vas tissue, including said isolated length ofvas deferens, and thereby separate said first area of clamped vas tissueinto two coagulated vas duct ends; h. removing said upper and lowercoagulating jaws from said first area of clamped vas tissue immediatelyafter step (g); and i. returning said coagulated vas duct ends to thescrotum.
 2. The method of claim 1, wherein said central slot is offsetfrom the longitudinal axis of the device by about 45 degrees.
 3. Themethod of claim 1, wherein said upper and lower coagulating jaws arearcuate in shape.
 4. The method of claim 3, wherein said upper and lowercoagulating jaws comprise mirror-image U-shaped curves.
 5. The method ofclaim 1, wherein said mating inner edges of said upper and lowercoagulating jaws comprise planar cutting edges and said outer edgesurfaces perimetral to said tissue-capturing distal end of said excisingclamp comprise curvilinear sharpened surfaces, whereby said excision ofsome or all of said second area of vas tissue, including said isolatedlength of vas deferens, is achieved through shearing action that arisesfrom engagement of said sharpened curvilinear surface with said planarcutting edges.